The study is designed to determine the optimal dose of Bronchitol and is being conducted in seven hospitals throughout Canada.
“This Canadian trial builds on our previously reported Australian study with Bronchitol, which demonstrated a significant clinical benefit for people with cystic fibrosis,” said Pharmaxis CEO Alan Robertson. “Our objective is to find the most suitable dose of Bronchitol for the important phase III clinical trials which are scheduled to commence mid 2006.”
All patients in the study will receive the same dose of Bronchitol twice daily for two weeks, and then will be randomized into three groups. Once randomized, patients will receive two weeks of treatment at one of three different doses followed by a week without Bronchitol, until all three doses have been evaluated.
The trial will measure changes in respiratory function, quality of life and the general health of the patient at each dose. Full patient recruitment is expected to take about six months.
Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis. The major difficulty in living with the disease is chronic lung congestion caused by poor lung hydration. Bronchitol is designed to tackle this problem, for which no products are currently available.